AdisInsight and searches for PDUFA dates

If you want to see which PDUFA dates are current (i.e. still pending) then use free text = PDUFA AND Update date is for change to Pre-registration for example, 1 year ago (or you can make it longer).

PDUFA dates are given usually around the time a regulatory submission is made; hence the reason for this search structure. Usually a submission is reviewed (in the US) within about 10-12 months; longer in the EU (<= 15 months).

You can then review each profile to understand whether the PDUFA dates are still current or whether the submission has already been approved for that indication, in which case the PDUFA date is obviously irrelevant.

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